PEDIATRIC ARTERIAL BLOOD FILTER

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

DELTA MEDICAL INDUSTRIES

The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Pediatric Arterial Blood Filter.

Pre-market Notification Details

Device IDK810068
510k NumberK810068
Device Name:PEDIATRIC ARTERIAL BLOOD FILTER
ClassificationFilter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant DELTA MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDTM  
CFR Regulation Number870.4260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-01-13
Decision Date1981-01-22

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